Posted by Scott L. Schofield on February 27, 2000, at 9:18:57
Pharmacia & Upjohn Receives FDA Approvable
Letter for VESTRA(TM)PEAPACK, N.J., Feb. 23 /PRNewswire/ -- Pharmacia & Upjohn announced today that the U.S. Food and Drug Administration (FDA) has issued a second approvable letter for the company's new antidepressant, VESTRA(TM) (reboxetine mesylate tablets).
This action requires the company to conduct an additional U.S. clinical study to augment the original New Drug Application (NDA) for VESTRA. The original NDA was accepted for filing by FDA in June 1998, based on studies conducted outside the U.S. Pharmacia & Upjohn is in the process of planning this additional U.S. study.
``We are confident about fulfilling the FDA's new request and look forward to bringing this important new class of antidepressants to the U.S. market,'' said Carrie Cox, Executive Vice President of Global Business Management.
VESTRA is currently marketed by Pharmacia & Upjohn in 18 countries, where it makes a valuable contribution to the treatment of depression.
Pharmacia & Upjohn is a global, innovation-driven pharmaceutical and health care company. Pharmacia & Upjohn's products, services and employees demonstrate its commitment to improve wellness and quality of life for people around the world.
This news release contains certain forward-looking statements, including, among other things, statements regarding the company's results of operations, regulatory actions, and expected closing date of the merger. These forward-looking statements are based on current expectations, but actual results may differ materially from anticipated future events or results. Certain factors which could cause the company's results to differ materially from expected and historical results are described in the company's periodic reports filed with the Securities and Exchange Commission, including the company's 1998 annual report on Forms 10-K and Exhibits 99 thereto.
The company has filed a definitive joint proxy statement/prospectus with the United States Securities and Exchange Commission (the ``SEC''), and other relevant information and documents concerning its merger with the Monsanto Company with the SEC. We urge investors to read the definitive joint proxy statement/prospectus and any other relevant documents to be filed with the sec, because they contain important information. Investors will be able to obtain the documents free of charge at the SEC's website, http://www.sec.gov. In addition, documents filed with the SEC by Pharmacia & Upjohn will be available free of charge from the Corporate Secretary of Pharmacia & Upjohn, 100 Route 206 North, Peapack, NJ 07977, Telephone 888-768-5501. Read the definitive joint proxy statement/ prospectus carefully before making a decision concerning the merger.
Pharmacia & Upjohn, its directors, executive officers and certain other members of management and employees may be soliciting proxies from Pharmacia & Upjohn stockholders in favor of the merger. Information concerning the participants in the solicitation is included in filings under Rule 425 made by Pharmacia & Upjohn with the SEC on January 27, 2000
Visit Pharmacia & Upjohn on the World Wide Web at http://www.pnu.com
VESTRA is a trademark of Pharmacia & Upjohn.
poster:Scott L. Schofield
thread:24259
URL: http://www.dr-bob.org/babble/20000220/msgs/24259.html